GC Biopharma to Present New IVIG Product Analyses and Host Patient Advocacy Symposium at IgNS 2026 Conference
GC Biopharma USA, Inc., a company specializing in plasma-derived products, has announced plans to present two new scientific analyses and host a patient advocacy symposium at the IgNS 2026 15th National Conference in Las Vegas, Nevada. The conference will take place from October 15 through October 18, 2026, bringing together healthcare professionals, researchers, and other stakeholders involved in immunoglobulin therapy and the management of immune-related conditions.
The company’s scientific presentations will focus on the aggregation characteristics of commercially available 10% intravenous immunoglobulin (IVIG) products and selected safety outcomes from the Phase 3 clinical study of ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid). In addition to sharing these findings, GC Biopharma will organize a symposium examining patient advocacy across geographical boundaries, with discussions addressing public policy, clinical education, and the individual experiences of people living with immune deficiencies.
The two posters will be presented during the IgNS poster session on Saturday, October 17, 2026, from 5:00 p.m. to 6:30 p.m. Pacific Daylight Time (PDT). The symposium, titled “Advocacy Across Borders: Global Perspectives, Individual Impact,” will take place earlier that day, from 7:30 a.m. to 9:00 a.m. PDT, in the Summerlin Ballroom.
Through these activities, GC Biopharma aims to contribute to the scientific understanding of IVIG products, provide additional information about selected safety outcomes associated with ALYGLO, and support discussions on the importance of patient advocacy in immune deficiency care.
Expanded Analysis Examines Aggregation Profiles Across Five IVIG Products
One of the company’s poster presentations will report findings from an expanded assessment of the aggregation profiles of five commercially available 10% IVIG products. The analysis evaluated multiple manufacturing lots to characterize differences in product composition and selected physical attributes.
The poster, titled “Expanded Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products,” builds on an examination of product characteristics by including six lots of ALYGLO and three lots each of four other commercially available 10% IVIG products.
IVIG products are manufactured from pooled human plasma and contain immunoglobulin G (IgG), an antibody that plays an important role in immune defense. These therapies are used in a range of clinical settings, including the treatment of certain primary and secondary immunodeficiency conditions and selected immune-mediated diseases.
Product quality and composition are important considerations in the development and manufacture of intravenous immunoglobulin therapies. Aggregation refers to the association of protein molecules into larger structures, while related product attributes can include monomer and dimer content, protein fragments, and particulate characteristics.
Evaluating these attributes across multiple manufacturing lots can help researchers better characterize product consistency and identify differences among commercially available formulations.
According to GC Biopharma, all five IVIG products evaluated in the expanded analysis demonstrated high purity and low aggregate levels. However, the investigators observed statistically significant differences among products in several measured characteristics.
These differences were identified in monomer and dimer content, fragment content, and particle size. By contrast, the analysis did not identify statistically significant differences in polymer levels or particle size dispersion.
The findings provide additional information about the physical characteristics of the evaluated products. Nevertheless, the company emphasized that further research is needed to establish the clinical relevance of the observed differences in aggregate-related attributes.
The study’s findings should therefore be interpreted as a comparative characterization of selected product properties rather than evidence that one IVIG product is clinically superior to another.
Multiple-Lot Assessment Provides Additional Product Characterization
The inclusion of multiple manufacturing lots is an important component of the expanded aggregation analysis. Examining several lots can provide a broader view of product characteristics than an assessment based on a single lot, helping investigators evaluate variability within and between products.
In this analysis, six ALYGLO lots were assessed alongside three lots from each of four other commercially available 10% IVIG products. This design allowed the investigators to compare selected characteristics across five products while incorporating information from multiple lots of each formulation.
The statistically significant differences in monomer and dimer content, fragment content, and particle size indicate that the measured attributes were not identical across the products examined. At the same time, the absence of statistically significant differences in polymer levels and particle size dispersion demonstrates that not every evaluated characteristic differed significantly.
These findings reinforce the importance of examining individual product attributes when assessing complex plasma-derived therapies. Differences identified through laboratory characterization may provide useful information for further research, but statistical significance alone does not establish that a difference will affect treatment outcomes.
Additional investigations would be necessary to determine whether the observed variations have meaningful implications for clinical performance, tolerability, or other patient-related outcomes.
GC Biopharma’s presentation is intended to contribute to the broader scientific discussion surrounding the characteristics of commercially available IVIG products and the importance of continued research into their composition and quality.
Phase 3 ALYGLO Analysis Provides Additional Safety Information
The second poster will present a post hoc descriptive review of selected events of special interest (ESIs) and serious adverse events (SAEs) from the Phase 3 clinical study of ALYGLO.
Titled “Safety in a Phase 3 Study of IVIG-stwk 10%: A Descriptive Review of Events of Special Interest (ESIs) and Serious Adverse Events (SAEs),” the analysis draws on information contained in the clinical study report (CSR).
The review was designed to provide additional characterization of selected safety outcomes that were not fully described in the original publication. Investigators conducted a CSR-only descriptive assessment using available subject-level information and reported subgroup characteristics, including age, sex, and infusion schedule.
The analysis examined treatment-emergent serious adverse events as additional context for understanding the safety findings. It also reviewed selected events of special interest associated with IVIG treatment, including thromboembolic events, renal outcomes, hematologic findings, blood chemistry changes, direct antiglobulin test (DAT)/Coombs findings, and viral safety considerations.
According to the company, the review identified no clinically meaningful thromboembolic, renal, hematologic, blood chemistry, DAT/Coombs, or viral safety signals.
The analysis also found that no treatment-related thromboembolic events, acute renal failure, deaths, or adverse event-related discontinuations were observed in the study.
These findings provide additional descriptive information about selected safety outcomes in the Phase 3 ALYGLO trial. However, the results should be considered in the context of the study population, the descriptive nature of the analysis, and the limitations of the available data.
In particular, the clinical trial excluded subjects with a history of thromboembolism and kidney disease. This exclusion criterion may limit the extent to which the findings can be generalized to patients who have these conditions or otherwise face an elevated risk of complications.
Consequently, the absence of observed treatment-related events in the study does not establish that such risks are absent in all patient populations. Further clinical experience and appropriately designed investigations may be needed to better characterize safety in groups that were not represented in the trial.
Understanding the Importance of Safety Assessments in IVIG Therapy
Safety evaluation is an essential component of clinical development for plasma-derived immunoglobulin therapies. Because IVIG products are administered intravenously and can be used in patients with complex underlying conditions, researchers assess a range of potential adverse outcomes during clinical trials.
Thromboembolic events and renal complications are among the outcomes that may warrant particular attention in IVIG safety assessments. Hematologic findings, changes in blood chemistry, and other laboratory observations may also be reviewed to provide a more comprehensive understanding of treatment tolerability.
The Phase 3 ALYGLO analysis offers additional detail about selected outcomes recorded in the clinical study report. By reviewing available patient-level information and reported subgroup characteristics, the investigators sought to provide a more detailed description of the safety experience documented during the trial.
The post hoc nature of the analysis is important when interpreting the findings. A descriptive review can help identify patterns and provide additional context, but it is not necessarily designed to establish causal relationships or determine the frequency of uncommon adverse events with precision.
Likewise, the lack of certain events in a clinical trial does not rule out their occurrence in broader clinical practice, particularly among patients with risk factors who were excluded from the study.
The company’s stated findings should therefore be viewed as supplementary information about the Phase 3 study rather than a definitive assessment of ALYGLO’s safety in every clinical setting.
By sharing the analysis at IgNS 2026, GC Biopharma intends to make additional information available to healthcare professionals and researchers who are interested in the clinical evidence supporting IVIG therapy.
GC Biopharma Highlights Scientific Research and Clinical Understanding
Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison in Medical Affairs at GC Biopharma USA, highlighted the importance of both presentations in expanding the available information about IVIG products and ALYGLO’s clinical safety profile.
“These analyses provide additional insight into both the characteristics of commercially available IVIG products and selected safety outcomes from the ALYGLO Phase 3 study,” Ness said.
She explained that expanding the aggregation assessment across multiple manufacturing lots strengthens the understanding of product-to-product differences. She also noted that the clinical study report analysis provides additional detail on events of special interest that were not fully characterized in the original publication.
The two studies address different but complementary areas of scientific interest. The aggregation analysis examines selected physical characteristics of commercially available products, while the Phase 3 review focuses on safety outcomes documented during the clinical evaluation of ALYGLO.
Together, the presentations are intended to contribute to ongoing discussions about product characterization, clinical safety assessment, and the evidence healthcare professionals may consider when evaluating immunoglobulin therapies.
The findings do not establish comparative clinical superiority or eliminate the need for individualized treatment decisions. Instead, they provide additional information for scientific evaluation and further research.
Patient Advocacy Symposium to Address Global Perspectives
Alongside its scientific posters, GC Biopharma will host the symposium “Advocacy Across Borders: Global Perspectives, Individual Impact” on Saturday, October 17, from 7:30 a.m. to 9:00 a.m. PDT in the Summerlin Ballroom.
The session will explore the role of patient advocacy in supporting individuals with immune deficiencies, with particular attention to public policy, clinical education, and the experiences of patients and their communities.
The symposium will feature three presenters:
- Lynn H. Albizo, JD, Chief Public Policy Officer at the Immune Deficiency Foundation.
- Suzanne Strasters, MSN-FNP, IgCN, Head of Clinical Education at GC Biopharma USA.
- Laura Remy-Martin, PhD, MPH, ACRP-CP, Field Medical Science Liaison at GC Biopharma USA.
The session is designed to bring together perspectives from patient advocacy, clinical education, and medical affairs to examine how advocacy initiatives can influence care for people living with immune deficiencies.
Patient advocacy organizations play an important role in representing the needs of affected individuals, raising awareness of disease-related challenges, and engaging with policymakers and healthcare stakeholders. Their activities may include legislative engagement, regulatory advocacy, patient education, and efforts to improve access to appropriate care.
The symposium will examine these issues through a global perspective while considering the impact that advocacy efforts can have on individual patients.
Immune Deficiency Advocacy and Public Policy
Lynn H. Albizo will discuss patient advocacy and public policy and their implications for people living with immune deficiencies. Her presentation will draw on her experience leading legislative and regulatory advocacy at the Immune Deficiency Foundation.
Public policy decisions can influence the healthcare environment in which patients receive treatment, including how medical needs are represented in policy discussions and how patient communities engage with healthcare institutions.
For people with immune deficiencies, advocacy can help communicate the challenges associated with diagnosis, ongoing treatment, access to specialized care, and the practical effects of living with a chronic condition.
By bringing these issues into a professional conference setting, the symposium aims to encourage discussion about the relationship between advocacy activities and the needs of individual patients.
The participation of clinical education and medical affairs professionals will provide additional perspectives on the importance of translating scientific and clinical information into resources that support healthcare professionals and patients.
The session also reflects the broader role of collaboration among biotechnology companies, healthcare providers, and advocacy organizations in addressing challenges that extend beyond the development of individual therapies.
GC Biopharma’s Longstanding Plasma Protein Expertise
GC Biopharma said its participation in IgNS 2026 reflects its commitment to advancing scientific understanding of IVIG therapies and supporting research that may help inform patient care.
The company has more than 50 years of experience in plasma protein manufacturing. Its work in this area provides the foundation for its focus on plasma-derived products and the scientific evaluation of their characteristics and clinical performance.
Plasma-derived therapies are manufactured from human plasma and undergo specialized processing and quality-control procedures. Research into their composition, manufacturing characteristics, and safety profiles contributes to the broader body of evidence supporting their use in appropriate clinical settings.
For GC Biopharma, the two poster presentations offer an opportunity to share additional findings on product aggregation and selected safety outcomes associated with ALYGLO. The patient advocacy symposium complements these scientific activities by highlighting the importance of understanding patient needs and supporting informed discussions about immune deficiency care.
Conference Presentation Details
The two scientific posters will be presented during the IgNS 2026 poster session on Saturday, October 17, from 5:00 p.m. to 6:30 p.m. PDT:
- Expanded Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products
- Safety in a Phase 3 Study of IVIG-stwk 10%: A Descriptive Review of Events of Special Interest (ESIs) and Serious Adverse Events (SAEs)
The patient advocacy symposium, “Advocacy Across Borders: Global Perspectives, Individual Impact,” will take place on the same day from 7:30 a.m. to 9:00 a.m. PDT in the Summerlin Ballroom.
The conference will run from October 15–18, 2026, in Las Vegas, Nevada.
Through its participation, GC Biopharma aims to contribute to ongoing research discussions surrounding IVIG product characteristics, the clinical safety profile of ALYGLO, and the role of advocacy in supporting patients with immune deficiencies.
The aggregation findings provide additional characterization of five commercially available IVIG products, while the post hoc Phase 3 analysis offers further descriptive information about selected safety outcomes. Although further research is required to establish the clinical relevance of the observed product differences and to understand safety in higher-risk populations, the presentations will add to the scientific information available for discussion among clinical researchers and healthcare professionals.
By combining these scientific presentations with a dedicated patient advocacy symposium, GC Biopharma is using the IgNS 2026 conference to emphasize both the importance of continued evidence generation and the need to consider patient experiences when advancing immune deficiency care.
About ALYGLO®
ALYGLO® (immune globulin intravenous, human-stwk) is a glycine-stabilized 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes multiple steps to reduce the risk of virus transmission. These include solvent/detergent treatment and 20 nm nanofiltration. The ALYGLO manufacturing process also uses G-XI™ Technology, its novel cation exchange (CEX) chromatography, that removes FXIa to undetectable levels.1,2 For more information about ALYGLO and G-XI™ Technology, visit www.alyglo.com.
About GC Biopharma
GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century.
About GC Biopharma USA
GC Biopharma USA, headquartered in Teaneck, NJ, is an operations and distribution company of GC Biopharma, that established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company GC Biopharma, a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide for more than 50 years. With GC Biopharma USA, GC Biopharma further extends its footprint, bringing its expertise and legacy to the US.